A LSTO N & B IR D LLP

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1 A LSTO N & B IR D LLP Health Care Public Policy Group Timeline of Key Health Reform Provisions Draft Date: 3/22/10 4:15 PM The chart below provides a timeline of the effective dates of key provisions in the Patient Protection and Affordable Care Act (H.R., signed into law on March 23, 2010, and the Health Care and Education Reconciliation Act of 2010 (H.R. 4872), as reported by the House Rules Committee on March 21, 2010 and passed by the Senate on March 25, The reconciliation bill is expected to be signed this week. We have included implementation dates for which there are specific statutory deadlines. Enactment Effective Upon Enactment Labeling Changes. Amends the Federal Food, Drug, and Cosmetic Act with respect to requirements applicable to the labeling of generic drugs. (Sec of H.R. Interagency Working Group on Health Care Quality. Creates an Interagency Working Group on Health Care Quality comprised of Federal agencies to collaborate on the development and dissemination of quality initiatives consistent with the national strategy. (Sec of H.R. Quality Measure Development. Authorizes $75 million over 5 years for the development of quality measures at AHRQ and CMS. (Sec of H.R. Clinical Practice Guidelines. Requires the Secretary to contract with the Institute of Medicine for the identification of existing and new clinical practice guidelines. (Sec of H.R. Health Care Delivery System Research; Quality Improvement Technical Assistance. Enables the Director of AHRQ to identify, develop, evaluate, disseminate, and provide training in innovative methodologies and strategies for quality improvement practices in the delivery of health care services that represent best practices in health care quality, safety, and value. (Sec of H.R. National Prevention, Health Promotion and Public Health Council. Establishes the National Prevention, Health Promotion and Public Health Council. (Sec of H.R. Prevention and Public Health Fund. Establishes a Prevention and Public Health Investment Fund to provide for investment in prevention and public health programs to improve health and help restrain the rate of growth in private and public sector health care costs. (Sec of H.R. 3509) School-Based Health Centers. Establishes a grant program for eligible entities to support the operation of school-based health centers. (Sec of H.R. Immunizations. Authorizes the Secretary to negotiate and enter into contracts with manufacturers of vaccines for the purchase and delivery of vaccines to adults. (Sec of H.R. Better Diabetes Care. Directs the Secretary of HHS to develop a national report card on diabetes to be updated every two years. (Sec of H.R. A tlan ta C h arlotte D allas L os A n g eles N ew Y ork R esearch T rian gle Silicon V alley V en tu ra C ounty W ash in gton,d.c.

2 Page 2 Enactment National Diabetes Prevention Program. Establishes a national diabetes prevention program targeted at adults at high risk for diabetes in order to eliminate the preventable burden of diabetes through community-based prevention services. (Sec (g)) of H.R. National Health Care Workforce Commission. Establishes a national commission tasked with reviewing health care workforce and projected workforce needs. (Sec of H.R. Federally Supported Student Loan Funds. Eases current criteria for schools and students to qualify for loans, shorten payback periods, and decreases the non-compliance provision to make the primary care student loan program more attractive to medical students. (Sec of H.R. Nursing Student Loan Program. Increases loan amounts and updates the years for nursing schools to establish and maintain student loan funds. (Sec of H.R. Public Health Workforce Recruitment and Retention Program. Establishes the Public Health Workforce Loan Repayment Program to ensure an adequate supply of public health professionals to eliminate shortages in federal, state, local, or tribal public health agencies. (Sec of H.R. Funding for National Health Service Corps. Increases and extends the authorization of appropriations for the National Health Service Corps scholarship and loan repayment program for (Sec of H.R. Nurse-Managed Health Clinics. Strengthens the health care safety-net by creating a $50 million grant program administered by HRSA to support nurse-managed health clinics. (Sec of H.R. Training in Family Medicine, General Internal Medicine, General Pediatrics, and Physician Assistantship. Provides grants and contracts to support and develop primary care training programs. (Sec of H.R. Training in General, Pediatric, and Public Health Dentistry. Reinstates dental funding in Title VII of the Public Health Service Act. (Sec of H.R. Advanced Nursing Education Grants. Strengthens language for accredited Nurse Midwifery programs to receive advanced nurse education grants in Title VIII of the Public Health Service Act. (Sec of H.R. Nurse Education, Practice, and Retention Grants. Awards grants to nursing schools to strengthen nurse education and training programs and to improve nurse retention. Authorizes such sums as may be necessary for (Sec of H.R. Nurse Faculty Loan Program. Establishes a Federally-funded student loan repayment program for nurses with outstanding debt who pursue careers in nurse education. (Sec of H.R. Fellowship Training in Public Health. Authorizes the Secretary to address workforce shortages in State and local health departments in applied public health epidemiology and public health laboratory science and informatics. (Sec of H.R. Counting Resident Time in Outpatient Settings and Allowing Flexibility for Jointly Operated Residency Training Programs. Modifies rules governing when hospitals can receive indirect medical education (IME) and direct graduate medical education (DGME) funding for residents who train in a non-provider setting so that any time spent by the

3 Page 3 Enactment resident in a non-provider setting shall be counted toward DGME and IME if the hospital incurs the costs of the stipends and fringe benefits. (Sec of H.R. Preservation of Resident Cap Positions from Closed Hospitals. Directs the Secretary to redistribute medical residency slots from a hospital that closes on or after the date that is two years before enactment of the this legislation based on certain criteria. (Sec of H.R. Increasing Teaching Capacity. Directs the Secretary to establish a grant program to support new or expanded primary care residency programs at teaching health centers. (Sec of H.R. Negotiated Rulemaking for Development of Methodology and Criteria for Designating Medically Underserved Populations and Health Professions Shortage Areas. Directs the Secretary, in consultation with stakeholders, to establish a comprehensive methodology and criteria for designating medically underserved populations and Health Professional Shortage Areas. (Sec of H.R. Provider Screening and Other Enrollment Requirements Under Medicare, Medicaid, and CHIP. Requires the Secretary to screen all providers and suppliers participating in Medicare, Medicaid, and CHIP. (Sec of H.R. Medicare and Medicaid Program Integrity Provisions. Requires CMS to complete development of the Integrated Data Repository (IDR), which would expand existing program integrity data sources and data sharing across Federal agencies. (Sec of H.R. 3509) Medicare Program Sanctions. Allows the Secretary to impose an appropriate administrative penalty if an individual knowingly participated in a Federal health care fraud offense or conspiracy to commit an offense. (Sec of H.R. Medicare Prepayment Medical Review Limitations. Repeals Section 1847A(h) of the SSA that relates to the conduct of prepayment review to allow Medicare Administrative Contractors to perform additional reviews to limit fraud and abuse. (Sec of H.R. 4872) Overpayments. Requires that any person who knows of an overpayment would be required to return the overpayment to the Secretary, the state, or a Medicare contractor. (Sec of H.R. Medicaid Statistical Information System. Permits the withholding of federal matching payments for states that fail to report enrollee encounter data in the Medicaid Statistical Information System. (Sec of H.R. Permissive Exclusions. Allows permissive exclusions for individuals or entities that knowingly make false statements or misrepresentations of material facts. (Sec of H.R. Deterrence/Civil and Criminal Penalties. Amends CMP law in several respects. Amends the Anti-Kickback statute so that a claim that includes items or services violating the statute would also constitute a false or fraudulent claim. (Sec of H.R. Subpoena Authority. Grants the Secretary subpoena authority in exclusion-only cases. (Sec of H.R. Surety Bond Requirements. Allows the Secretary to determine surety bond requirements for DME and home health providers based on an amount commensurate with the volume of

4 Page 4 Enactment the billing of the provider. (Sec of H.R. Suspension of Payments. Secretary may suspend Medicare and Medicaid payments to a provider or supplier pending an investigation of fraud. (Sec of H.R. Program Integrity Funding and Reporting Requirements. Health Care Fraud and Abuse Control (HCFAC) program funding would be increased by $10 million each year for 10 years, and would remain available until expended. Permanently applies the CPI adjustment to HCFAC and Medicare Integrity Program funding. (Sec of H.R. Medicare and Medicaid Integrity Programs. Requires entities that are enrolled in Medicare and Medicaid to submit performance statistics on the number of fraud referrals, overpayments recovered, and return on investment. (Sec of H.R. Transition from Healthcare Integrity and Protection Data Bank to the National Practitioner Data Bank. Requires Secretary to maintain a data collection program for the reporting of final adverse actions against health care providers. (Sec of H.R. Medicare Payment. For services furnished before January 1, 2010 claims must be submitted no later than December 31, (Sec of H.R. Termination of Provider Participation. Terminates a provider s participation in Medicaid if enrollment under Medicare or another state plan is terminated. (Sec of H.R. Medicaid Exclusion from Participation. Requires State Medicaid agencies to exclude from Medicaid participation for a period any entity that owns, controls, or manages an entity or is owned, controlled, or managed by an individual or entity that has unpaid overpayments, is suspended or excluded from participation, or is affiliated with an entity that has been suspended or excluded. (Sec of H.R. Required Registration under Medicaid. Requires agents, clearinghouses, and other alternate payees to register under Medicaid. (Sec of H.R. Overpayments. Extends the period for collection of overpayments from 60 days to 1 year. (Sec of H.R. Prohibition on False Statements and Representations. Prohibits any person, in connection with a plan or other arrangement that is a multiple employer welfare arrangement, from making a false statement in connection with the marketing or sale of such plan. (Sec of H.R. Development of Model Uniform Report Form. Requires the Secretary to request that the National Association of Insurance Commissioners (NAIC) develop a model uniform report form for private health insurance issuers seeking to refer suspected fraud and abuse to state insurance departments. (Sec of H.R. Applicability of State Law to Combat Fraud and Abuse. Allows the Secretary to adopt regulatory standards or issue an order establishing that a person engaged in the business of providing insurance through a multiple employer welfare arrangement is subject to the laws of the states in which such person operates which regulate insurance. (Sec of H.R. Issue of Summary Cease and Desist Orders. Allows the Secretary of Labor to issue cease and desist orders and summary seizure orders against multiple employer welfare arrangements (MEWAs), if the Secretary determines the MEWA is in a financially hazardous condition. (Sec of H.R. MEWA Plan Registration with the Department of Labor. MEWAs must register with the

5 Page 5 Enactment Secretary of Labor. (Sec of H.R. Permitting Evidentiary Privilege and Confidential Communications. Secretary may provide for evidentiary privilege and confidential communications between certain federal agencies during investigations, audits, examinations, or inquiries. (Sec of H.R. Health Care Fraud Enforcement. Increases the federal sentencing guidelines for health care fraud. Changes the intent requirement for fraud under the Anti-Kickback statute such that a person need not have actual knowledge of this section or specific intent to violate this section. (Sec of H.R. Required Disclosure of Ownership and Additional Disclosable Parties Information. Requires that SNFs under Medicare and nursing facilities (NFs) under Medicaid make available on request by the Secretary, the Inspector General of the Department of Health and Human Services, the States, and the State long-term care ombudsman, information on ownership, including a description of the governing body and organizational structure of the facility and information regarding additional disclosable parties. (Sec of H.R. Accountability Requirements for SNFs and NFs. Requires SNFs and NFs to implement a compliance and ethics program to be followed by the facility s employees and its agents within 36 months of enactment, and requires the Secretary to evaluate this program and report the results to Congress. (Sec of H.R. Nursing Home Compare Medicare Website. Requires the Secretary to publish the certain information on the Nursing Home Compare Medicare website. (Sec of H.R. Reporting of Expenditures. Requires the Secretary to modify cost reports for SNFs to require reporting of expenditures on wages and benefits for direct care staff, breaking out registered nurses, licensed professional nurses, certified nurse assistants, and other medical and therapy staff. (Sec of H.R. Nationwide Program for National and State Background Checks on Direct Patient Access Employees of Long Term Care Facilities and Providers. Requires the Secretary to establish a nationwide program for national and State background checks on direct patient access employees of certain long-term supports and services facilities or providers. (Sec of H.R. Extension of Physician Fee Schedule Mental Health Add-On. Increases the payment rate for psychiatric services by 5 percent for two years, through the end of (Sec of H.R. Pharmacy Benefit Managers Transparency Requirements. Requires Pharmaceutical Benefit Managers (PBMs) or a qualified health benefits plan offered through an exchange to provide to the Secretary, and in the case of a PBM, to the plan with which the PBM is under contract with certain information. (Sec of H.R. Additional Requirements for Charitable Hospitals. Establishes additional requirements to quality as a section 501(c)(3) charitable hospital organization, including conducting community needs assessments. (Sec of H.R. Exclusion for Assistance Provided to Participants in State Student Loan Repayment Programs for Certain Health Professionals. Excludes from gross income any amount received under any State loan repayment or loan forgiveness program that is intended to provide for the increased availability of health care services in underserved or health professional shortage areas. (Sec of H.R.

6 Page 6 Enactment Implementation Funding. Creates a $1,000,000,000 Health Insurance Reform Implementation Fund within HHS for implementation on the Patient Protection and Affordable Care Act and the Reconciliation Act. (Sec of H.R. 4872) Access to Therapies. Prevents the HHS Secretary from promulgating regulations that create unreasonable barriers to individuals obtaining medical care. (Sec of H.R. Freedom Not to Participate in Federal Health Insurance Programs. Provides that no individual, company, business, nonprofit entity, or health insurance issuer shall be required to participate in any Federal health insurance program created under this Act. (Sec of H.R. Improving Women s Health. Establishes an Office of Women s Health in the Office of the Secretary, the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, the Agency for Healthcare Research and Quality, the Health Resources and Services Administration, and the Food and Drug Administration. (Sec of H.R. Oversight. The Inspector General of the Department of HHS shall have oversight authority with respect to the administration and implementation of title I related to quality affordable health care for all Americans. (Sec of H.R. Qualifying Therapeutic Discovery Project Credit. Creates a 2-year temporary tax credit to an overall cap of $1,000,000,000 to encourage investments in new therapies to prevent, diagnose, and treat acute and chronic diseases. (Sec of H.R. Labeling Changes. Amends the Federal Food, Drug, and Cosmetic Act with respect to requirements applicable to the labeling of generic drugs. (Sec of H.R. Health Care Fraud. Requires enhanced screening procedures for health care providers to eliminate fraud and waste in the health care system. (Sec of H.R. Extension of LTCH MMSEA Provisions. Extends Sections 114 (c) and (d) of the Medicare, Medicaid and SCHIP Extension Act of 2007 by two years. (Sec of H.R. Simplification of Annual Beneficiary Election Periods. Provides an annual 45 day period for beneficiaries to disenroll from MA plans and elect to enroll in FFS Medicare. Allows beneficiaries to disenroll from a MA plan and return to FFS Medicare from January 1 to March 15 of each year. (Sec of H.R. Technical Correction to MA Private FFS plans. Extends applicability of the 2008 service area extension waver for MA coordinated care plans to employers that contract directly with MA. (Sec of H.R. Making Senior Housing Facility Demonstration Permanent. Allows MA plans that operate in continuing care retirement communities and provide specified services to continue to operate under the MA program. (Sec of H.R /1/2010 Expanded Participation in the 340B Program. Expands list of covered entities eligible to receive discounted prices under the 340B Program to outpatient children s cancer, and critical access hospitals as well as certain sole community hospitals and rural referral centers. Exempts orphan drugs from expansion. (Sec of H.R and Sec of H.R. 4872) Prescription Drug Rebates. Increases Medicaid rebate percentage for outpatient single source and innovator multiple source prescription drugs from 15.1% to 23.1% (except for

7 Page 7 1/1/2010 certain clotting factors and outpatient drugs for pediatric indications, for which the basic rebate would increase to 17.1%). (Sec of H.R. Prescription Drug Rebates. Increases rebate for non-innovator, multiple source drugs to 13 percent of AMP. (Sec of H.R. Prescription Drug Rebates. Applies additional rebate for new formulations of existing drugs to line extensions of a single source drug or an innovator multiple source drug that are an oral solid dosage form. (Sec of H.R and Sec of H.R. 4872) Prescription Drug Rebates. Extends Medicaid rebates to Managed Care Organizations. (Sec of H.R. Evidence-Based Coverage of Preventive Services in Medicare. Authorizes the Secretary to modify the coverage of certain preventive services covered by Medicare and the coverage of the services included in the initial preventive physical examination, to the extent that such modification is consistent with the recommendations of the U.S. Preventive Services Task Force. (Sec of H.R. Medicare Payment. The maximum period for submission of Medicare claims on or after January 1, 2010 would be reduced to not more than 12 months. (Sec of H.R. Requirements for Physicians to Provide Documentation on Referrals to Programs at High Risk of Waste and Abuse. Allows the Secretary to revoke enrollment for a period of not more than one year for each act for a physician or supplier who fails to maintain or does not provide access to documentation relating to written orders or requests for payment for DME, certifications for home health services, or referrals for other items or services specified by the Secretary. (Sec of H.R. Face to Face Encounter with Patient Required before Physicians may Certify Eligibility for Home Health Services or Durable Medical Equipment Under Medicare. Requires physicians to have a face-to-face encounter with patients prior to certification or recertification for home health services or DME under Medicare. (Sec of H.R. Enhanced Penalties. Amends and enhances application of civil monetary penalties. (Sec of H.R. Required Reporting Under Medicaid Management Information System (MMIS). Requires entities (including managed care organizations) to report additional data elements under MMIS as the Secretary determines necessary. (Sec of H.R. Disclosure Requirements for In-Office Ancillary Services Exception to the Prohibition on Physician Self-Referral for Certain Imaging Services. Amends requirement to the in-office ancillary exception of the Stark law. (Sec of H.R. Limitation on Excessive Remuneration Paid by Certain Health Insurance Providers. Creates a special rule under section 162(m) regarding the deductibility of excessive remuneration (including deferred deduction remuneration) by an insurance provider. (Sec of H.R. Modification of Section 833 Treatment of Certain Health Organizations. Requires that nonprofit Blue Cross Blue Shield organizations have a medical loss ratio of 85 percent or higher in order to take advantage of the special tax benefits provided to them under section 833 of the IRC. (Sec of H.R. Expanded Participation in the 340B Program. Expands list of covered entities eligible to receive discounted prices under the 340B Program. Exempts orphan drugs from expansion. (Sec of H.R and Sec of H.R. 4872)

8 Page 8 1/1/2010 Prescription Drug Rebates. Increases Medicaid rebate percentage for outpatient single source and innovator multiple source prescription drugs from 15.1% to 23.1% (except for certain clotting factors and outpatient drugs for pediatric indications, for which the basic rebate would increase to 17.1%). (Sec of H.R. Prescription Drug Rebates. Increases rebate for non-innovator, multiple source drugs to 13 percent of AMP. (Sec of H.R. Prescription Drug Rebates. Applies additional rebate for line extensions of a single source drug or an innovator multiple source drug that are an oral sold dosage form. (Sec of H.R. 4872) Prescription Drug Rebates. Extends Medicaid rebates to Managed Care Organizations. (Sec of H.R. Part B Premium Adjustment. Freezes income thresholds at 2010 levels through 2019 for income-related premium for Part B Medicare. (Sec of H.R. Small Business Tax Credit. Initiates first phase of the small business tax credit for qualified small employers for contributions to purchase health insurance for employees. The credit is up to 35% of the employer s contribution to provide health insurance for employees. There is also up to a 25 percent credit for small nonprofit organizations. Effective calendar year (Later, when Exchanges are operational, tax credits will be up to 50% of premiums.) (Sec of H.R. Medicaid Global Payments Demonstration. Requires the Secretary, in coordination with the CMS Innovation Center, to establish a demonstration project in up to five states from 2010 to 2012, under which a large, safety net hospital system participating in Medicaid would be permitted to alter its provider payment system from a fee-for-service structure to a capitated, global payment structure. (Sec of H.R. Medicaid and CHIP Payment and Access Commission (MACPAC) Assessment of Policies Affecting All Medicaid Beneficiaries. Authorizes $11 million for MACPAC for FY2010, of which $9 million would come from Medicaid funds and $2 million would come from CHIP funds. (Sec of H.R. Funding to Expand State Aging and Disability Resource Centers. Appropriates, to the Secretary of HHS, $10 million for each of FYs 2010 through 2014 to carry out Aging and Disability Resource Center (ADRC) initiatives. (Sec of H.R. Extension of the Work Geographic Index Floor. Extends the 1.0 floor for the geographic index for physician work through (Sec of H.R. Extension of Payment for Technical Component of Certain Physician Pathology Services. Extends a provision that directly reimburses qualified rural hospitals for certain clinical laboratory services through the end of (Sec of H.R. Modification of Equipment Utilization Factor for Advanced Imaging Services. Increases the utilization rate assumption for advanced diagnostic imaging equipment from 50 percent to 65 percent for ; to 70 percent for 2013; and to 75 percent for 2014 and subsequent years. (Sec of H.R. Payment for Bone Density Tests. Restores payment for dual-energy x-ray absorptiometry (DXA) services furnished during 2010 and 2011 to 70 percent of the Medicare rate paid in (Sec of H.R. Extension of Outpatient Hold Harmless Provision. Extends the existing outpatient hold

9 Page 9 1/1/2010 harmless provision through the end of FY2010 and would allow Sole Community Hospitals with more than 100 beds to also be eligible to receive this adjustment through the end of FY2010. (Sec of H.R. Rural Physician Training Grants. Directs the Secretary, acting through HRSA, to establish a grant program for purposes of assisting eligible entities in recruiting students mostly likely to practice in underserved rural communities, providing rural-focused training and experience, and increasing the number of recent allopathic and osteopathic medical school graduates who practice in rural communities. Appropriates $4,000,000 for each of the FYs 2010 through (Sec of H.R. 3/1/2010 Providing Federal Coverage and Payment Coordination for Dual Eligible Beneficiaries. Establishes the Federal Coordinated Health Care Office (CHCO) within CMS no later than March 1, (Sec of H.R. 4/1/2010 Home Health Rural Add-On Payment. Reinstates a 3 percent per episode add-on payment for rural home health providers from April 1, 2010 through (Sec of H.R. Ensuring Medicaid Flexibility for States. Allows States to cover parents and childless adults up to 133 percent of FPL and receive current law Federal Medical Assistance Percentage (FMAP). Effective April 1, (Sec of H.R.. Hospital Wage Index Improvement. Extends reclassifications under section 508 of the Medicare Modernization Act (P.L ) through the end of FY2010. Beginning on April 1, 2010, the Secretary shall include the average hourly wage data of hospitals whose reclassification was extended only if including such data results in a higher applicable reclassified wage index. (Sec of H.R. Payment Update: LTCH. Requires market basket minus 0.25%. (Sec of H.R. Payment Update: Hospitals (Inpatient and Outpatient), Inpatient Psych. and IRFs. Requires market basket minus 0.25%. (Sec of H.R. 4/23/2010 Transparency in Government. Not later than 30 days after the date of enactment of this Act, the Secretary shall publish on the HHS website a list of all of the authorities provided to the Secretary under this Act. (Sec of H.R. 5/1/2010 Medication Management Services in Treatment of Chronic Disease. Establishes a program to provide grants or contracts to eligible entities to implement medication management ( MTM ) services provided by licensed pharmacists. (Sec of H.R. 3509) 5/23/2010 Immediate Access to Insurance for Uninsured Individuals with a Pre-Existing Condition. Requires the Secretary to create a temporary insurance high-risk pool program within 90 days of enactment to provide insurance to people who have been uninsured for 6 months and have a pre-existing condition. The program terminates in 2014 when the Exchanges are operational. (Sec of H.R. Reducing Cost of Covering Early Retirees. Requires the Secretary to establish a temporary reinsurance program to provide reimbursement to participating employment-based plans for part of the cost of providing health benefits to retirees (age 55-64) and their families (until Jan. 1, 2014). (Sec of H.R. 7/1/2010 Requirements Related to Durable Medical Equipment and Home Health. Requires physicians, who order durable medical equipment or home health services that are billable to Medicare, to be Medicare participating physicians or eligible professionals, as determined by the Secretary. (Sec of H.R. Improving Consumer Information through the Web. Requires the Secretary of HHS to

10 Page 10 7/1/2010 establish an Internet website through which residents of any State may identify affordable health insurance coverage options in that State. (Sec of H.R.. 9/23/2010 Improvements to the 340B Program Integrity. Not later than 180 days after the Act s enactment, Secretary is required to make certain improvements to the 340B Program. (Sec of H.R. Demonstration Project to Provide Access to Affordable Care. Not later than 6 months after the Act s enactment, the Secretary, acting through HRSA, shall establish a 3-year demonstration in 10 states to provide access to comprehensive health care services to the uninsured at reduced fees. (Sec of H.R. Provider Self-Disclosure Protocol. Within 180 days, the Secretary would be required to develop a mechanism for providers to voluntarily disclose specific information regarding actual and potential violations of the physician self-referral law. (Sec of H.R. Improvements to the 340B Program Integrity. Requires the Secretary to make certain improvements to the 340B Program. (Sec of H.R. Health Insurance Standards. Requires the Secretary to develop standards for use by health insurers in compiling and providing an accurate summary of benefits and explanation of coverage to be provided to applicants, enrollees, and policyholders. (Sec. 1001, adding Sec. 2715, of H.R. Prohibiting Rescissions. Prohibits individual and group plans from rescinding coverage except in instances of fraud or intentional misrepresentation of material fact and with prior notice given to enrollees. (Sec. 1001, adding Sec. 2712, of H.R. Eliminating Lifetime Limits. Prohibits insurers from imposing lifetime limits on benefits. (Sec. 1001, adding Sec. 2711, of H.R. Regulating Use of Annual Limits. Regulates plans use of annual limits to ensure access to needed care in all group plans and all new individual plans. Effective six month after enactment and applying to new plans in the individual market and all employer plans. (When the Exchanges are operational in 2014, the use of annual limits will be banned for new plans in the individual market and all employer plans.) (Sec. 1001, adding Sec. 2711, of H.R. Preventive Health Services. Requires individual and group plans to cover and not impose cost-sharing on preventive services and immunizations. (Sec. 1001, adding Sec. 2713, of H.R. Appeals Process. Requires insurers to implement an effective process for appeals of coverage determinations and claims. Requires plans to maintain both internal and external appeals processes. (Sec. 1001, Sec. 2719, of H.R. Extending Coverage for Young Adults. Requires individual and group plans offering dependent coverage to allow unmarried individuals up to age 26 to remain covered as dependents. (Sec. 1001, adding Sec. 2714, of H.R. Grants to Collect Reimbursement Data. Provides grants to States to establish academic or non-profit medical reimbursement data centers to collect medical reimbursement information from health insurers to analyze, and to make such information available to issuers, providers, researchers, policymakers, and the general public; and to develop fee schedules and other database tools that reflect market rates for medical services and the geographic difference in those rates and would also make information available to the public through a website. (Sec of H.R.

11 Page 11 9/23/2010 Patient Protections. Requires insurers to allow enrollees to designate any participating primary care provider (or pediatrician for children) who is available to accept the individual as the enrollee s primary care provider. Requires covered benefits for emergency department services to be covered without prior authorization requirements and without regard to whether the provider furnishing services is a participating provider. Prohibits plans from requiring authorization or referral for female patients seeking obstetrical or gynecologic care. (Sec. 1001, Sec. 2719A, of H.R. Bringing Down the Cost of Health Care Coverage (Standard Hospital Charges Reporting). Requires hospitals to publicize a list of standard charges for items and services provided by the hospitals, including DRGs. (Sec. 1001, adding Sec. 2718, of H.R. Health Information Technology Enrollment Standards and Protocols. Requires, within 180 days after enactment, the Secretary to develop standards and protocols, in consultation with the HIT Policy and Standards Committees, to promote the interoperability of systems for enrollment of individuals in Federal and State health and human services programs. (Sec. 1561, of H.R. 10/1/2010 Approval Pathways for Biosimilar Biological Products. Requires Secretary to develop recommendations to Congress with respect to user fees. (Sec of H.R. Coverage of Comprehensive Tobacco Cessation Services for Pregnant Women in Medicaid. Requires states to cover diagnostic, therapy, and counseling services and pharmacotherapy (including prescription and nonprescription tobacco cessation agents) for cessation of tobacco use by pregnant women who use tobacco products or who are being treated for tobacco use by or under the supervision of a physician or any other authorized health care professional. (Sec of H.R. Primary Care Extension Program. Creates a Primary Care Extension Program to educate and provide technical assistance to primary care providers about evidence-based therapies, preventive medicine, health promotion, chronic disease management, and mental health. (Sec of H.R. National Correct Coding Initiative. Requires states to use the National Correct Coding Initiative. (Sec of H.R. Revisions to SNF Provisions. Requires the Secretary to implement the concurrent therapy change and changes to the look-back period to ensure that only those services furnished after admission are included in determining case mix classification. (Sec of H.R. State Demonstration Programs to Evaluate Alternatives to Current Medical Tort Litigation. Authorizes states to conduct demonstration programs to evaluate alternatives to current medical tort litigation. (Sec of H.R. Approval Pathways for Biosimilar Biological Products. Requires Secretary to develop recommendations to Congress with respect to user fees. (Sec of H.R. Strengthening Community Health Centers. Provides funds to build new and expand existing community health centers. (Sec of H.R. Application of Budget Neutrality on a National Basis in the Calculation of the Medicare Hospital Wage Index Floor. Starting on October 1, 2010, the provision would require application of budget neutrality associated with the effect of the imputed rural and rural floor to be applied on a national, rather than State-specific basis through a uniform, national adjustment to the area wage index. (Sec of H.R.

12 Page 12 12/31/2010 Limitation on Medicare Exception to the Prohibition on Certain Physician Referrals for Hospitals. Prohibits physician-owned hospitals that do not have a provider agreement prior to December 31, 2010 from participating in Medicare. (Sec of H.R and Sec of H.R. 4872) Extension of Exceptions Process for Medicare Therapy Caps. Extends the process allowing exceptions to limitations on medically necessary therapy until December 31, (Sec of H.R. Expansion of the Recovery Audit Contractor (RAC) Program. Not later than December 31, 2010, expands RAC program to Medicaid and Medicare Parts C and D. Requires RACs to ensure that MA and PDPs implement anti-fraud plans. (Sec of H.R /1/2011 Providing Adequate Pharmacy Reimbursement Limits. Changes the FUL to no less than 175 of the weighted average of the most recent AMPs for pharmaceutically and therapeutically equivalent multiple source drugs available nationally through commercial pharmacies. Clarifies definition of AMP. (Sec of H.R and 1101 of H.R. 4872) Community-Based Care Transitions Program. Requires the Secretary to establish a 5-year program under which the Secretary would provide funding to hospitals and communitybased entities that furnish evidence-based care transition services to Medicare beneficiaries at high risk for readmission. (Sec of H.R. National Strategy. Establishes a Federal health care quality internet website. (Sec of H.R. State Option to Provide Health Homes for Enrollees with Chronic Conditions. Creates a new Medicaid state plan option under which enrollees with at least two chronic conditions, or with one chronic condition and at risk of developing another, or with at least one serious and persistent mental health condition, could designate a provider, a team of health care professionals, or a health team as their health home. (Sec of H.R. Medicare Coverage of Annual Wellness Visit Providing a Personalized Prevention Plan. Provides coverage under Medicare for an annual wellness visit where individuals are provided a personalized prevention plan services. (Sec of H.R. Removal of Barriers to Preventive Services in Medicare/Amendment Relating to Waiving Coinsurance for Preventive Services. Waives coinsurance in all settings (co-payment and deductible) for certain preventive and screening services, an initial preventive physical examination, and personalized prevention plan services. (Sec and of H.R. Training Opportunities for Direct Care Workers. Provides grants for entities to provide new training opportunities for direct care workers employed in long-term care settings. (Sec 5302 of H.R. 90-Day Period of Enhanced Oversight for Initial Claims of DME Suppliers. Permits the Secretary to withhold payment to DME suppliers initially enrolling in the Medicare program who are within a category or geographic area deemed to be at significant risk of fraudulent activity for 90 days. (Sec of H.R. 4872). National Provider Identifier. Requires the Secretary to promulgate a regulation no later than January 1, 2011 requiring all providers and suppliers that qualify for a national provider identifier to include this identifier on all applications for enrollment. (Sec of H.R. Expanding Access to Primary Care Services and General Surgery Services. Provides

13 Page 13 1/1/2011 primary care practitioners, as well as general surgeons practicing in health professional shortage areas, with a 10 percent Medicare payment bonus for five years. (Sec of H.R. Productivity Adjustment. Implements a full productivity adjustment for laboratories, DME, and ambulatory surgical centers. (Sec of H.R. Fee schedule reduction for Clinical Laboratories. For , reduces the annual fee schedule update by 1.75 percent after the productivity adjustment. (Sec. 3401(l) of H.R. Inclusion of Cost of Employer-Sponsored Health Coverage on W-2. An employer would be required to disclose the value of the benefit provided by the employer for each employee s health insurance coverage on the employee s annual Form W-2. (Sec of H.R. Distribution for Medicine Qualified Only if for Prescribed Drug or Insulin. Provides that nontaxable reimbursements from health flexible spending accounts (FSAs), health reimbursement arrangements (HRAs), and health savings accounts (HSAs) do not include a medicine or drug unless the medicine or drug is prescribed or is insulin. (Sec of H.R. Increase in Additional Tax on Distributions from HSAs and Archer MSAs not Used for Qualified Medical Expenses. Increases the additional tax for HSA withdrawal prior to 65 that are used for purposes other than qualified medical expenses from 10 to 20 percent. (Sec of H.R. Imposition of Annual Fee on Branded Prescription Pharmaceutical Manufacturers and Importers. Imposes a $2,300,000,000 aggregate fee on all manufacturers and importers with gross receipts from branded prescription drug sales to be paid to the Secretary of the Treasury. (Sec of H.R and Sec of H.R. 4872) Establishment of Simple Cafeteria Plans for Small Business. Provides a safe harbor from the nondiscrimination requirements for eligible small employers that maintain simple cafeteria plans. (Sec of H.R. Providing Adequate Pharmacy Reimbursement Limits. Changes the FUL to no less than 175 of the weighted average of the most recent AMPs for pharmaceutically and therapeutically equivalent multiple source drugs available nationally through commercial pharmacies. Clarifies definition of AMP. (Sec of H.R. Providing New, Voluntary Options for Long-Term Care Insurance ( CLASS Program). Creates a long-term care insurance program to be financed by voluntary payroll deductions to provide benefits to adults who become disabled. (Sec of H.R. Reporting on Premium Dollars. Health plans, including grandfathered plans, must annually report on the share of premium dollars spent on medical care and provide consumer rebates for excessive medical loss ratios. (Sec of H.R. Medical Loss Ratio Requirements. Health insurers must begin providing a rebate to each enrollee if the amount the insurer spends on clinical services provided to enrollees and activities that improves health care quality does not exceed 85% of premium revenue for large groups (80% for small groups). (Sec. 1001, adding Sec. 2718, of H.R. Home Health Outlier Cap. Provider-specific annual cap of 10% of revenues on Home Health agency outlier reimbursements. (Sec of H.R. Payment Update: LTCH. Requires market basket minus 0.5%. (Sec of H.R. Payment Update: Home Health. Requires market basket minus 1%. (Sec of H.R.

14 Page 14 1/1/2011 Long-Term Care Ombudsman Program Grants and Training. Appropriates $5 million for FY 2011, $7.5 million for FY 2012, and $10 million for each of FYs 2013 and 2014 for grants to eligible entities to support the long-term care ombudsman program. Appropriates $10 million for each of FYs 2011 through 2014 for the Secretary to establish programs to provide and improve ombudsman training related to elder abuse. (Sec adding Sec. 2043, of H.R. Hospice Reform. This provision would require the Secretary to update Medicare hospice claims forms and cost reports by Based on this information, the Secretary would be required to implement changes to the hospice payment system to improve payment accuracy in FY2013. (Sec of H.R. Permitting Physician Assistants to order Post-Hospital Extended Care Services. Authorizes physician assistants to order skilled nursing care services in the Medicare program beginning in (Sec of H.R. Payment for Imaging Services. Sets the utilization rate assumption for expensive diagnostic imaging equipment (equipment priced over $1 million) at 75 percent for 2011 and subsequent years. (Sec of H.R. 4872) Public Reporting of Performance Information. Requires the Secretary of HHS to develop by January 1, 2011 a Physician Compare website with information on physicians enrolled in the Medicare program and other eligible professionals who participate in the PQRI program. (Sec of H.R. Payment Update: Clinical Labs. Reduces update for clinical laboratories by 1.75 percent in each of (Sec of H.R. Payment Update: DME. For covered items of durable medical equipment and prosthetic devices and orthotics and prosthetics, sets the annual update at CPI for 2011 and subsequent years (subject to the productivity adjustment below). (Sec of H.R. Benefit Protection and Simplification. Prohibits MA plans from charging beneficiaries cost sharing for chemotherapy, dialysis services, skilled nursing care, and other designated service that is greater than that charged under FFS Medicare. Effective in (Sec of H.R. Authority to Deny Plan Bids. Beginning in 2011, authorizes the Secretary to deny bids submitted by MA plans that propose to significantly increase beneficiary cost sharing or decrease benefits. (Sec of H.R. Protections for Frontier States. Starting in FY 2011, for hospitals and physicians located in states in which at least 50% of the counties in the state are frontier (i.e. less than 6 people per square mile), establishes a hospital wage index floor of 1.00, a hospital outpatient department wage adjustment factor floor of 1.00, and a geographic practice expense floor for physician services of The 1.00 floor would not apply to hospitals or services in a state that receives a non-labor related adjustment (Alaska and Hawaii). (Sec of H.R. Subsidy-Eligible Individuals under PDPs and MA PD plans. Allows Part D plans that bid a nominal amount above the regional low-income subsidy (LIS) benchmark to absorb the cost of the difference between their bid and the LIS benchmark in order to remain a $0 premium LIS plan. Authorizes the Secretary to auto-enroll subsidy eligible individuals in plans that waive de minimis premiums. Effective date January 1, (Sec of H.R.

15 Page 15 1/1/2011 Establishment of Center for Medicare and Medicaid Innovation within CMS. Establishes within the Centers for Medicare and Medicaid Services (CMS) a Center for Medicare & Medicaid Innovation. The purpose of the Center will be to research, develop, test, and expand innovative payment and delivery arrangements (models) to improve the quality and reduce the cost of care provided to patients in each program. Appropriates $5 million from the Treasury not otherwise appropriated for the design, implementation, and evaluation of models for DY 2010; and appropriates $10 billion for Center activities over 10 years. (Sec of H.R. 3/23/2011 Advancing Research and Treatment for Pain Care Management. Not later than 1 year after funds are appropriated to carry out this section, the Secretary shall seek to enter into an agreement with Institute of Medicine to convene a conference on pain management. (Sec of H.R. Advancing Research and Treatment for Pain Care Management. Not later than 1 year after the Act s enactment establishes an Interagency Pain Research Coordinating Committee to coordinate all efforts within HHS and other federal agencies that relate to pain research. (Sec of H.R. GAO Study and Report on Medicare Beneficiary Access to High-Quality Dialysis Services. Directs the Comptroller General to submit to Congress, within one year of enactment, a study on the impact on Medicare beneficiary access to high-quality dialysis services of the end stage renal disease prospective payment system. (Sec of H.R. 7/1/2011 Payment Adjustment for Health Care-Acquired Conditions (HACs). Prohibits Federal payments to states for Medicaid services related to HACs. (Sec of H.R. Distribution of Additional Residency Positions. Directs the Secretary to redistribute residency positions that have been unfilled for the prior three cost reports and directs those slots for training of primary care physicians. (Sec of H.R. Treatment of Certain Complex Diagnostic Laboratory Tests. Creates a 2-year demonstration program to test the impact of direct payments for certain complex laboratory tests on Medicare quality and costs. (Sec of H.R. Payment Adjustment for Health Care-Acquired Conditions (HACs). Effective July 1, 2011, prohibits Federal payments to states for Medicaid services related to health care acquired conditions. (Sec of H.R. 9/23/2011 GAO Study to Make Recommendations on Improving the 340B Program. Requires GAO to make recommendations on improvements to the Program with 18 months of the Act s enactment. (Sec of H.R. 9/30/2011 Extension of Gainsharing Demonstration. The Deficit Reduction Act of 2005 authorized a demonstration to evaluate arrangements between hospitals and physicians designed to improve the quality and efficiency of care provided to beneficiaries. This provision would extend the demonstration through September 30, (Sec of H.R. 10/1/2011 Graduate Nurse Education Demonstration Program. This provision directs the Secretary to establish a demonstration program for up to 5 eligible hospitals to increase graduate nurse education training under Medicare. (Sec of H.R. Revisions to SNF Provisions. Delays the implementation of certain SNF RUGs-IV payment system changes by one year. (Sec of H.R. Community First Choice Option. Establishes an optional Medicaid benefit through which States could offer community-based attendant services and supports to Medicaid beneficiaries with disabilities who would otherwise require the level of care offered in a hospital, nursing facility, or intermediate care facility for the mentally retarded. (Sec and Sec of H.R.

16 Page 16 10/1/2011 Home Health and SNF Value-Based Purchasing Plan. Due date for consideration. (Sec of H.R /1/2012 Demonstration Project to Evaluate Integrated Care Around a Hospitalization. Establishes a bundled payment demonstration project under Medicaid in up to 8 states, which will begin on January 1, 2012 and end on December 31, (Sec of H.R. Independence at Home Demonstration Program. Not later than January 1, 2012, creates a new demonstration program for chronically ill Medicare beneficiaries to test a payment incentive and service delivery system that utilizes physician and nurse practitioner directed home-based primary care teams aimed at reducing expenditures and improving health outcomes. (Sec of H.R. Community Mental Health Centers. Requires community mental health centers that provide at least 40 percent of their services to individuals not eligible for Medicare to meet new requirements for receiving Medicare billing privileges. Effective for items and services furnished on or after the first day of the first calendar quarter that is at least 12 months from the date of enactment. (Sec of H.R. 4872) Pediatric ACO Demonstration Project. Establishes a demonstration project from January 1, 2012 to December 31, 2016 for states, which would allow pediatric medical providers who meet certain criteria to be recognized as accountable care organizations (ACOs). (Sec of H.R. Medicare Shared Savings Program. Not later than January 1, 2012, requires the Secretary to establish a shared savings program that would reward ACOs that take responsibility for the costs and quality of care received by their patient panel over time. (Sec of H.R. Productivity Adjustment. Beginning in 2012, implements a full productivity adjustment for inpatient and outpatient hospital services, inpatient psychiatric facilities, inpatient rehabilitation, long term care hospital services, ESRD, and SNFs. (Sec of H.R. Transparency Reports and Reporting of Physician Ownership or Investment Interests. Preempts state law, unless state law is beyond the scope of this section. (Sec of H.R. Prescription Drug Sample Transparency. Not later than April of each year, each drug manufacturer and authorized distributer of record shall submit to the Secretary information with respect to the preceding year on the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed during that year. (Sec of H.R. Demonstration Project to Evaluate Integrated Care Around a Hospitalization. Establishes a bundled payment demonstration project under Medicaid in up to 8 states, which will begin on January 1, 2012 and end on December 31, (Sec of H.R. Payment Update: Home Health. Requires market basket minus 1%. (Sec of H.R. Payment Update: Hospitals (Inpatient and Outpatient), Inpatient Psychiatric, IRFs, and LTCHs. Requires market basket minus 0.1%. (Sec of H.R. Full Productivity Adjustment. Hospitals (Inpatient and Outpatient), Inpatient Psychiatric, IRFs, LTCHs, SNFs, and ESRD will receive an annual full productivity adjustments (equal to the 10-year moving average of changes in annual economy-wide private nonfarm